Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090084
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/22/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2019 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/21/2018 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/11/2018 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-5 REMS - PROPOSAL - D-N-A

Label is not available on this site.

OXYCODONE AND ASPIRIN

TABLET;ORAL; 325MG;4.8355MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription No AA 090084 ACTAVIS LABS FL INC
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription No AA 091670 MAYNE PHARMA INC
PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG TABLET;ORAL Prescription Yes AA 007337 ENDO PHARMS

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